The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study

This is a multi-center, observational study to evaluate the safety and probable benefit of
the AMPLATZER™ PIVSD Occluder for use in transcatheter closure of muscular ventricular septal
defects following a myocardial infarction in the post approval setting.

The study has five endpoints (safety: acute and chronic survival; effectiveness: technical
success, acute and chronic closure).Two cohorts will be utilized to obtain study endpoint
data. The first cohort will be comprised of all available Emergency and Compassionate PIVSD
Occluder subject data from 2011 until the end of 2016 and these data will be used to
determine technical success and acute survival. The second cohort of thirty subjects will be
comprised of patients who are successfully implanted with a PIVSD Occluder from 2011 onward
at activated study centers. The index procedure must have occurred >6 months prior to
enrollment. Subject identification will occur until data on a minimum of 30 subjects with
PIVSD Occluders for post myocardial infarct VSD and post-procedure echocardiogram available
for evaluation of residual shunt by the echocardiography core laboratory have been enrolled.
The thirty subject cohort data will be used to determine acute closure, chronic closure, and
chronic survival endpoints.

The study will be conducted at up to 50 centers in the U.S. The expected duration of
enrollment is approximately 2 years. The total duration of the clinical study is expected to
be 2.5 years.

First Cohort:

Patients who have undergone an attempt to close a post-infarct VSD using the AMPLATZER™
PIVSD Occluder via Emergency and Compassionate 2011 until the end of 2016.

Second Cohort:

- Over 18 years old

- Patients who have previously been successfully implanted with the AMPLATZER™ PIVSD
Occluder

- Subject or subject's legally authorized representative has provided consent to
participate in this study

- Subject's post-procedure echocardiogram is evaluable and can be sent to the
echocardiography core laboratory for residual shunt assessment